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** Caredalud S.R. (Tizanidine 6 mg) 30 Sustained-Release F.C. Scored Tablets. Centrally acting skeletal muscle relaxant.
** Composition:
Each Sustained-Release F.C. Scored Tablet contains:
Tizanidine HCl 6.864 mg Eq. to Tizanidine 6 mg
** Indications:
Tizanidine is a short-acting drug for the acute and intermittent management of increased muscle tone associated with spasticity. The reduction of muscle tone that follows the oral administration of a single dose of tizanidine has its peak effect 1 to 2 hours after dosing, and the effect dissipates between 3 to 6 hours. Use must therefore be individualized, directed to those activities and times when relief of spasticity is most important and titrated to avoid intolerance. Evidence demonstrating the effectiveness of tizanidine is derived from a single dose study and from a 7 week multiple dose study conducted in patients with multiple sclerosis and spinal cord injury, respectively.
# Painful muscle spasms:
– associated with static and functional disorders of the spine (cervical and lumbar syndromes).
– Following surgery, e.g. for herniated intervertebral disc or for osteoarthritis of the hip.
# Spasticity due to neurological disorders e..g multiple sclerosis, chronic myelopathy, degenerative diseases of the spinal cord, cerebrovascular accidents and cerebral palsy.
** Warning:
Clinical experience with long-term use of tizanidine at doses of 8 to 16 mg single doses or total daily doses of 24 to 36 mg is limited. In safety studies, approximately 75 patients have been exposed to individual doses of 12 mg or more for at least one year or more and approximately 80 patients have been exposed to total daily doses of 30 to 36 mg / day for at least one year or more.
There is essentially no long-term experience with single, daytime doses of 16 mg. Because long-term clinical study experience at high doses is limited, only those adverse events with a relatively high incidence are likely to have been identified.
** Dosage:
– For the relief of painful muscle spasms: 1 to 3 mg three times daily. In severe cases an extra dose of 2 or 4 mg may be taken at night.
– For spasticity due to neurological disorders: The initial daily dose should not exceed 6 mg given in 3 divided doses. It may be increased stepwise at half-weekly intervals by 2 to 4 mg. The optimal therapeutic response is generally achieved with a daily dose between 12 and 24 mg, administered in 2 or 4 equally spaced doses. The daily dose of 36 mg should not be exceeded.
** Precautions:
– This drug should be administered with caution for patients with renal insufficiency (creatinine clearance less than 25 mL/min) and impaired liver function. It is recommended to start treatment with a dosage of 2 mg once daily to be increased gradually according to tha patient affording and effectiveness of drug. First it is advised to increase the dose taken once daily before increasing number of administrations.
– It is important to warn patients who feel lethargic when starting therapy from activities which require high level of awakeness such as driving or operating machinery.
– Safety of using the drug during pregnancy has not been ensured.
– Clinical experience with using the drug by children is still limited and it is not known if it is safe for infants whose mothers use the drug.
** Keep at room temperature.
Keep out of the reach of children.
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